Fat Grafting in Skin-grafted Deep Burn Scars

Burn Scar Clinical Trial

Official title:

Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627650
• Other study ID #: EC 2010/ 572
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: October 1, 2016

Study information

• Verified date: August 2018
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up

Description:

Objective: A randomised clinical trial was performed to determine the effect of autologous fat grafting on scar formation in early skin-grafted deep burn wounds.

Methods: Included patients received split-thickness skin grafting procedures for deep burn wounds less than 3 months ago. A homogenous scar area in each patient was divided into two equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting, the adjacent part with transcutaneous saline injection as control. Results were evaluated by clinical assessment with scar scale questionnaires, histological examination, and objective scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 1, 2016
• Est. primary completion date: September 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• early skin-grafted deep burn scars

• otherwise healthy

Exclusion Criteria:

• concomitant disease

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix

Intervention

Procedure:
• lipofilling/ fat grafting
liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous
• placebo injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of scar quality by histological assessment	histology of scar tissue, scoring by 2 independent blinded anatomopathologists, (numerical scoring of fibroblast activity, collagen and elastin organisation, vascularity) scoring range min 1(close to normal tissue) - 3 (scar characteristics)	6 months
Primary	improvement of scar quality by physiological testing with cutometer	measures elasticity of the scar; micrometer; higher values better outcome	6 months, 1 year
Primary	Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale	numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation	1 year
Primary	Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale	numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief	1 year
Primary	improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter)	measures transepidermal water loss; g/m2/h; higher values worse outcome	6 months, 1 year
Primary	physiological testing of scar tissue by corneometer	measures hydration of the epidermis; corneometer units, higher values better outcome	6 months, 1 year